BioAlliance notes positive final results for doxorubicin Transdrug trial

By Elaine Rigoli

Tampa, Fla., Sept. 19 - BioAlliance Pharma SA said the phase 1/ 2 clinical trial of its doxorubicin Transdrug for primary liver cancer has produced encouraging results.

The French pharmaceutical company said the main objective was to determine the maximum tolerated dose which can be used in subsequent clinical trials and secondly to measure the efficacy of doxorubicin Transdrug.

During the trial, 20 patients suffering from advanced liver cancer received at least one intra-arterial hepatic injection of doxorubicin Transdrug. Tolerance and efficacy data from this trial resulted in the selection of a 30 mg/m2 dose to be used for further clinical development of the treatment.

In the sub-group of patients who received the 30 mg/m2 dose, the efficacy measurements show promising results for doxorubicin Transdrug with an objective response of 16.67% after a single injection.

A recent study presented to the American Society of Clinical Oncology gastro-intestinal meeting earlier in 2006 showed an objective response of only 4% to intravenous injections of doxorubicin in patients with advanced liver cancer.

After a centralized radiological review, the disease showed a disease control in 60% of patients (disease control in 12 out of 20 patients) with five partial responses and seven stabilizations.

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